Description:

Zoladex LA injection  is a long-acting gonadotropin-releasing hormone (GnRH) agonist depot formulation. It suppresses sex hormone production (testosterone in men, estradiol in women) by down-regulating the pituitary-gonadal axis. It is primarily used for palliative treatment of hormone-dependent advanced prostate cancer in men (suitable for hormonal manipulation), and in some regions for endometriosis or uterine fibroids in women (though the 10.8mg strength is often male-focused or restricted in indications for females due to estradiol suppression data). The “LA” denotes long-acting (3-month depot).

Prescription: Prescription-only (Rx). Administered only by a healthcare professional (doctor or nurse) via subcutaneous injection; requires specialist oversight (e.g., oncologist/urologist) with monitoring of hormone levels, PSA (in prostate cancer), bone density, and side effects.

Therapeutic Category:

Antineoplastic hormone antagonist / GnRH agonist / LHRH analog (for endocrine therapy in hormone-sensitive cancers and gynecological conditions).

Active Ingredients/Composition:

Active ingredient: Goserelin acetate equivalent to 10.8 mg goserelin (goserelin base). The implant is a sterile, biodegradable cylindrical rod of lactide/glycolide copolymer (D,L-lactic and glycolic acids copolymer) impregnated with goserelin acetate. No additional active ingredients.

Vitamins: None.

Minerals: None.

Variant: 10.8 mg long-acting (LA) depot implant (3-month formulation; differs from Zoladex 3.6 mg monthly depot; single-dose pre-filled syringe with SafeSystem needle for subcutaneous administration).

Consume Type:

Subcutaneous implant (depot injection; small pellet inserted under the skin of the anterior abdominal wall below the navel line; not oral or self-administered).

Directions/Usage: Administered by a healthcare professional using aseptic technique.

• Standard dose: One 10.8 mg implant injected subcutaneously into the anterior abdominal wall every 12 weeks (3 months).
• For prostate cancer: Often initiated with anti-androgen cover (e.g., bicalutamide) for first 4 weeks to prevent tumor flare; continue long-term unless contraindicated.
• In some indications (e.g., breast cancer or endometriosis): Every 12 weeks, but confirm with specialist as female use may prefer 3.6 mg monthly in certain guidelines.
• Adhere strictly to 12-week schedule (slight delay of a few days permissible; up to 16 weeks in some data without loss of suppression).
• Monitor hormone levels (testosterone/estradiol), PSA, bone health, and symptoms regularly.

Common Side Effects:

• Hot flushes/sweating (very common)
• Reduced libido/sexual dysfunction, erectile dysfunction, testicular atrophy
• Injection site reactions (pain, redness, swelling)
• Bone density loss (osteoporosis risk with long-term use)
• Fatigue, headache, dizziness
• Weight gain, mood changes (e.g., depression)
• Breast tenderness/enlargement (gynecomastia in men)
• In men: Tumor flare symptoms initially (e.g., bone pain, urinary issues) Serious/rare: Cardiovascular events (QT prolongation), thromboembolic events, pituitary apoplexy, hypersensitivity, convulsions. Seek immediate help for severe symptoms like chest pain, shortness of breath, or allergic reactions.

Package Type:

Single-dose pre-filled syringe (with SafeSystem protective sleeve and 14-16 gauge needle) containing one 10.8 mg implant (sterile pouch with desiccant and administration instructions; often supplied as 1 implant per pack).

Storage Advice: Store at room temperature (below 25-30°C; do not store above 30°C), protected from moisture and light. Keep in original sealed pouch until ready for use. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only by trained professionals; incorrect injection risks complications.
• Contraindicated in known hypersensitivity to goserelin or GnRH analogs, pregnancy (Category X—teratogenic), or severe untreated depression without monitoring.
• Caution in patients with osteoporosis risk factors (monitor bone density; consider bisphosphonates), cardiovascular disease (QT prolongation risk), or urinary obstruction (initial flare may worsen).
• Tumor flare in prostate cancer: Use anti-androgen cover initially.
• Long-term use: Monitor for metabolic changes, cardiovascular risk, bone loss.
• Pregnancy/breastfeeding: Not for use in females planning pregnancy; effective contraception required during/after treatment in premenopausal women.
• Report any new/worsening symptoms (e.g., mood changes, bone pain) to doctor.

Product Substitutes: Other goserelin formulations: Zoladex 3.6 mg (monthly depot, same manufacturer). Alternatives for prostate cancer: Leuprolide (Lupron Depot, Eligard), triptorelin (Decapeptyl), buserelin, or degarelix (Firmagon—GnRH antagonist, no flare). For hormone-sensitive cancers: Anti-androgens (e.g., bicalutamide, enzalutamide), abiraterone, or orchiectomy. Consult oncologist/urologist for equivalents per local guidelines (e.g., Ghana cancer protocols often include GnRH agonists like Zoladex).

Manufacturer/Marketer:

AstraZeneca (original innovator; in some markets distributed/marketed by TerSera Therapeutics or affiliates post-licensing; AstraZeneca Pharma India or global affiliates for exports).

Country of Origin:

Varies by batch/market—commonly United Kingdom (AstraZeneca UK Limited), Sweden (AstraZeneca manufacturing sites), or other EU/US facilities. In Ghana/West Africa, imported from UK/EU or via AstraZeneca distributors.